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# MDUFA 4 Discussion of 510(k)s, PMAs Delayed
- URL: https://www.fdaweb.com/mdufa-4-discussion-of-510-k-s-pmas-delayed/
- Published: 2016-01-28T12:00:00.000Z
- Updated: 2026-09-15T02:31:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134591

> Issues that did not receive full discussion due to time constraints at a 12/15/15 MDUFA $ reauthorization meeting included 510(k) total time to decision reduction, third-party 510(k) review, digital health, leveraging standards, device-specific guidance, PMA process enhancements and total product life cycle, access to review summaries, and deficiencies traced to references. Just-released meeting [minutes](http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM480738.pdf?ref=fdaweb.com) say FDA staff noted that they had provided some requested data on 513(g) submissions before the meeting and acknowledged that AdvaMed, MDTA, and MITA may present a 513(g) proposal at the 1/20 negotiation meeting.  
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> The two sides discussed establishing working groups to address technical details about personnel recruitment, IT, complex topics for pre-submissions, pre-submissions/SIMS, *de novo*, CLIA waivers, mechanisms for addressing workload uncertainty, and the PMA proposals. They agreed to develop the working group logistics over the next two weeks with a goal of holding technical working group discussions early in January so that key discussion points may be reported at the 1/20 meeting.  
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> Participants also discussed details of their respective proposal packages. FDA presented in-depth information for several proposals, including review process infrastructure, Q-submissions, *de novo*, CLIA waivers, patient-centered data, evidence from real world experience, and mechanisms for addressing workload uncertainty. The two sides discussed questions and general observations about remaining proposals, but did not have a detailed discussion due to time constraints. They agreed to form working groups to further address proposals that require focused work by subject matter experts.